Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K181044 |
Device Name |
400um Perforator and Accessory Vein Ablation Kit |
Applicant |
AngioDynamics, Inc. |
26 Forest Street |
Marlborough,
MA
01752
|
|
Applicant Contact |
Deepa R. Godhiya |
Correspondent |
AngioDynamics, Inc. |
26 Forest Street |
Marlborough,
MA
01752
|
|
Correspondent Contact |
Deepa R. Godhiya |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 04/19/2018 |
Decision Date | 07/05/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02215369
|
Reviewed by Third Party |
No
|
Combination Product |
No
|